JP2008000594A - Articulating blunt dissector/gastric band application device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an articulating blunt dissector/gastric band application device. <P>SOLUTION: This single handed articulating blunt dissector/gastric band application device includes a supporting shaft for connecting a handle which is provided on a first end section of the device to an articulating assembly which is provided on a second end section of the device while being a supporting shaft. The handle includes an actuation mechanism which is linked to the articulating assembly in order to operate under the control. The second end section includes a proximal end section and a distal end section. The distal end section is formed to dissect a tissue without unduly causing trauma to the tissue, and also includes a dimension-determined blunt distal end section. Also, the second end section includes a suture grasping notch shaped and dimensioned in order to pull a gastric band by engaging with the gastric band. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

Disclosure details

(Field of the Invention)
The present invention relates to a gastric band attachment device. In particular, the present invention relates to articulating blunt dissector / gastric band application devices.

BACKGROUND OF THE INVENTION
Morbid obesity is a serious medical condition. In fact, morbid obesity is very widespread in the United States and other countries, and the trend seems to be going bad. Complications associated with morbid obesity include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, a number of orthopedic problems, and pulmonary valve insufficiency that significantly shorten lifespan. For this reason, the financial and physical costs associated with morbid obesity are substantial, as will be appreciated by those skilled in the art. In fact, the costs associated with morbid obesity are estimated to exceed $ 100 billion in the United States alone.

  Various surgical methods have been developed to treat obesity. The most common surgical method currently performed is Roux-en-Y gastric bypass (RYGB). This method is highly complex but is commonly used to treat morbidly obese patients. Other methods of bariatric surgery may include Fobi pouch, bilio-pancreatic diversion, and gastroplasty or “stomach stapling”. In addition, implantable devices that limit the food that passes through the stomach and provide a feeling of fullness are also known.

  Because many of these surgical procedures are highly invasive, attempts have been made to develop low traumatic and minimally invasive surgical procedures. The gastric band method is a type of gastric reduction surgery that attempts to reduce the stomach and limit food intake. The gastric band method, unlike RYGB and other gastric reduction methods, does not require changes to the gastrointestinal anatomy in the duodenum and jejunum.

  Since the early 1980s, gastric bands have become an effective alternative to gastric bypass and other irreversible surgical weight loss treatments for morbid obesity. Several alternative methods are performed under the name of the gastric band method. Some band technologies use gastric rings, other band technologies use gastric bands, some band technologies use gastric staples, and some other procedures use a combination of rings, bands, and staples. . The most commonly performed procedures are wrap band, vertical band gastroplasty (VBG), silastic ring gastroplasy (SRG), and adjustable silastic gastric band. Law (AGB: adjustable silastic gastric banding).

  Generally, the gastric band surrounds the upper portion of the patient's stomach and forms a small hole that is smaller than the normal inner diameter of the stomach. This limits the flow of food from the upper part of the stomach to the lower digestive part. If the stoma is of an appropriate size, the food held at the top of the stomach provides a feeling of fullness and prevents overeating.

  Typically, the gastric band is introduced into the patient's abdomen by laparoscopically pushing the gastric band through the trocar. Various delivery devices have been developed for this purpose. However, currently available delivery devices are not limited, but are difficult to sterilize, require both hands for proper operation, and have low strength when moving in the key directions. There are numerous problems such as. Accordingly, there is a need for an improved gastric band delivery device that allows convenient and reliable delivery of gastric bands. The present invention provides such a gastric band delivery technique.

[Summary of the Invention]
Accordingly, it is an object of the present invention to provide a single handed articulating blunt dissector / gastric band application device. The device includes a support shaft that connects a handle provided at a first end of the device to an articulating assembly provided at a second end of the device. The handle includes an actuation mechanism coupled to the articulation assembly for actuating the articulation assembly under control. The second end includes a proximal end and a distal end, the distal end being shaped and dimensioned to incise tissue without undue trauma to the tissue. Includes a blunt distal tip. The second end also includes a suture grasping notch that is shaped and dimensioned to engage and pull the gastric band.

  Another object of the present invention is also to provide a device in which the suture retaining notches are oriented with an inclination relative to the longitudinal axis of the device.

  Yet another object of the present invention is to provide a device in which the suture retaining notches are oriented at an angle of 45 ° with respect to the longitudinal axis of the device.

  Yet another object of the present invention is to provide a device in which the articulation assembly is oriented proximally relative to the suture retaining notch.

  It is another object of the present invention to provide an apparatus in which the articulation assembly includes a flexible member comprising a first side member and a second side member.

  Yet another object of the present invention is a device wherein the first side member and the second side member are substantially parallel and spaced apart from each other when extending along the second end of the device. Is to provide.

  Another object of the invention is that the first side member includes an inner surface with a plurality of necked down regions and the second side member includes an inner surface with a plurality of collared constrictions. To provide an apparatus.

  Yet another object of the present invention is to provide an apparatus in which a restraining band is attached around a flexible member.

  Yet another object of the present invention is an apparatus wherein the actuating mechanism includes a flexing finger and the articulating assembly can be articulated by holding and moving the flexible finger. Is to provide.

  Another object of the present invention is that the flexible finger includes a constant stress beam that is connected to the first end of the handle from the second end of the handle. Has a tapered down cross section as it extends over the section, allowing the flexible fingers to bends down into a smooth arc To provide an apparatus.

  Another object of the present invention is that the actuating mechanism includes a cable having a first end and a second end, the first end of the cable being coupled to a flexible finger, The second end is coupled proximate to the articulation assembly so that when the flexible finger is bent, the cable moves and stretches over the increased arc length. The object is to provide an apparatus capable of covering the length.

  It is a further object of the present invention to provide an apparatus including a first pulley and a second pulley around which a cable is wound to amplify the displacement of the cable.

  Other objects and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, illustrating certain embodiments of the present invention.

[Detailed explanation]
Detailed embodiments of the present invention are disclosed herein. However, it is to be understood that the disclosed embodiments are merely examples of the invention that can be embodied in various forms. Accordingly, the details disclosed herein are not to be construed as limiting, but merely serve as a basis for the appended claims, as well as methods of making and / or using the present invention. It is the basis for teaching to the traders.

  With reference to FIGS. 1, 2, and 3, a one-hand articulating blunt dissector / gastric band attachment device 10 is disclosed. The device 10 includes a first end 12 and a second end 14. The first end portion 12 usually includes a handle 16 and an operating mechanism 18, which will be described in detail later. The second end 14 comprises an articulation assembly 20 that is configured to engage and manipulate the gastric band 100 during delivery as well as incising tissue. A handle 16 provided on the first end 12 of the device 10 is provided on the second end 14 of the device 10 between the first end 12 and the second end 14 of the device 10. A support shaft 22 is provided for connection to the articulation assembly 20. One skilled in the art will appreciate that the device 10 can be manufactured from a variety of biocompatible materials suitable for a particular application of the present invention.

  As can be seen from the following disclosure, the second end 14 of the device 10 includes a proximal end 24 and a distal end 26. The distal end 26 includes a blunt distal tip 28 that is shaped and dimensioned to cut tissue without undue trauma to the tissue. Near the distal tip 28 of the distal end 26 of the second end 14 of the device 10, the second end 14 is also located in the stomach via a retrogastric esophageal window. A suture retaining notch 30 is provided for engaging the band 100 and pulling the gastric band 100. Referring to commonly-owned US Pat. No. 5,522,788 (named “Finger-like laparoscopic blunt dissector device”), which is incorporated herein by reference, The gastric band 100 generally includes a suture loop 102 extending from the gastric band 100. The suture loop 102 holds the end of the gastric band 100 and attaches the gastric band 100 around the stomach. Therefore, the contact member can be pulled.

  In view of this, the second end 14 of the present attachment device 10 is adapted to receive a suture loop 102 so that the gastric band 100 can be easily manipulated when attaching the gastric band 100 around the stomach. A notched 30 is formed and dimensioned. According to a preferred embodiment, the notch 30 is oriented with an inclination relative to the longitudinal axis 32 of the device 10 (ie, when the device 10 is in a linear configuration). More specifically, the notch 30 is oriented at an angle of 45 ° with respect to the longitudinal axis 32 of the device 10 in an angled direction toward the first end 12 of the device 10. As described above, the articulation assembly 20 is disposed at the second end 14 of the device 10. However, because the articulation assembly 20 is oriented proximally with respect to the previously described notch 30, the articulation assembly is used for use of the notch 30 when wrapping the gastric band 100 around the patient's stomach. The assembly 20 can be used to reorient the notch 30 in a new direction. In general, articulation assembly 20 is located between proximal end 24 and distal end 26 of second end 14 of apparatus 10. Articulation assembly 20 includes a flex member 34. The flexible member 34 consists of a single piece of flex material that can bend when one side moves relative to the other. According to a preferred embodiment, the flexible material is nylon, but polyethylene and polypropylene are also good materials for use in the production of flexible materials. Although specific materials are disclosed herein, other flexible materials can certainly be used without departing from the inventive concept. Specifically, the flexible member 34 includes a first side member 36 and a second side member 38. The first side member 36 and the second side member 38 are substantially parallel and spaced apart from each other when they extend along the second end 14 of the apparatus 10. The first side member 36 and the second side member 38 are relatively movable so as to form a flexible characteristic, the details of which will be described later.

  The first side member 36 of the flexible member 34 includes a first end 40 and a second end 42, and the second side member 38 of the flexible member 34 is a first end 44. , And a second end 46. The first end 40, 44 of each of the first side and second side members 36, 38 of the flexible member 34 are joined to define a distal end 48 of the flexible member 34; Finally, it extends to the distal end 26 of the second end 14 of the device 10 and includes the suture loop retaining notch 30 as described above.

  The first side member 36 includes a substantially smooth outer surface 50. The inner surface 52 of the first side member 36 includes a plurality of collar-shaped constricted portions 54. The collar-shaped constricted portion 54 is easy to bend by reducing the strength of the first side member 36 at a predetermined position along the first side member 36 and minimizing the force of the joint operation necessary for the movement of the first side member. To do. Similarly, the second side member 38 includes a substantially smooth outer surface 56. The inner surface 58 of the second side member 38 includes a plurality of collar-shaped constricted portions 60. The collar-shaped constricted portion 60 reduces the strength of the second side member at a predetermined position along the second side member 38, and makes it easy to bend by minimizing the joint operation force necessary for the movement of the second side member. . The collared constrictions 54, 60 of the first and second side members 36, 38 allow controlled bending of the flexible member 34, and the smooth outer surfaces 50, 56 cause excessive trauma to adjacent tissue. The movement through the body cavity and tissue of the device 10 is possible without giving.

  A restraining band 62 is attached around the flexible member 34 to prevent the first side member 36 and the second side member 38 from bending away from each other when a load is applied in accordance with the present invention. ing. The restraining band 62 bends together with the flexible member 34 to prevent the first side member 36 and the second side member 38 of the flexible member 34 from separating from each other. Although a restraint band 62 is disclosed in accordance with a preferred embodiment of the present invention, other restraint members, such as, for example, a tension coil spring, can be used without departing from the concept of the present invention. Utilizing the restraining band 62 (or other restraining structure) bends the first side member 36 and the second side member 38 without bending outward when tension is applied to bend the articulation assembly 20. It is very important to be able to apply force to the flexible member 34 in the opposite direction as well as in the direction. By using the restraining band 62, the flexible member 34 is symmetric and can be bent in both directions, allowing articulation exceeding 180 °.

  As described above, the first end 12 of the device 10 includes an actuation mechanism 18 that is used to control the bending of the flexible member 34. Actuating mechanism 18 includes flexible fingers 64 integrally formed with handle 16. The flexible fingers 64 are generally elongated members that bend easily. The user can articulate the flexible member 34 described above by holding and moving the flexible finger 64.

  Specifically, a central opening 80 in which the flexible finger 64 is disposed is formed in the handle 16. The central opening 80 includes a first end 82 and a second end 84, and the first end 86 of the flexible finger 64 is the handle 16 at the first end 82 of the central opening 80. Is bound to. The remaining portion of the flexible finger 64 is spaced from the handle 16. Thus, the flexible finger 64 is positioned within the central opening 80 about the first end 86 of the flexible finger 64 when pressure is applied along the second end 88 of the flexible finger 64. You can turn at.

  According to a preferred embodiment, the flexible fingers 64 are made of nylon, but polyethylene and polypropylene are also good materials for use in the production of flexible materials. Although specific materials are disclosed herein, other flexible materials can certainly be used without departing from the inventive concept. As will be appreciated from the disclosure below, the flexible finger 64 uses a spar with a constant stress (a constriction with a tapered cross section), so the flexible finger 64 is And can be bent so as to be constricted into a smooth arc, and stress is not concentrated on the first end 86 or the second end 88 of the flexible finger 64.

  Because the traction cable 66 is slidably coupled to the flexible finger 64, when the flexible finger 64 is bent, the traction cable 66 moves and extends over an increased arc length; This length can be covered. In addition to cable 66, according to a preferred embodiment, pulleys 68, 70 can be used to amplify the movement of the cable that articulates flexible member 34. For example, a first or palm pulley 68 disposed at the first end 72 of the handle 16 proximate the first end 86 of the flexible finger 64 and a second end 88 of the flexible finger 64. The second or tip pulley 70 located at the end can be fixed or freely rotatable. The traction cable 66 is wound around the palm pulley 68 and extends to the first end 72 of the handle 16 where it is secured. In this manner, the movement of the cable 66 is converted into the movement of the elements of the flexible fingers 64, thereby articulating the flexible member 34.

  Specifically, according to a preferred embodiment, cable 66 includes a first end 74 and a second end 76. The first end 74 is secured to the first end 72 of the handle and the second end 76 is secured to the second end 14 of the device 10 at a position beyond the flexible member 34. ing. The cable 66 is of such a length that it will be slightly stretched when the device 10 is straight and will be pulled when the flexible finger 64 is bent in a predetermined direction (one skilled in the art will see preferred embodiments). Thus, it will be appreciated that the cable 66 will loosen when the flexible finger 64 bends in another direction).

  The fixing point of the flexible finger 64 and the first end 74 of the cable 66 is provided at the fixing point of the cable 66 provided at the second end 14 of the device 10 and at the first end 12 of the device 10. The effective length between the fixed points of the cable 66 can be easily changed. Specifically, since the cable 66 is oriented on the outer surface of the flexible finger 64, when the flexible finger 64 is bent in a concave shape when viewed from the side surface on which the cable 66 extends, the second of the apparatus 10. The effective length between the fixed point of the cable 66 provided at the end 14 of the cable and the fixed point of the cable 66 provided at the first end 12 of the apparatus 10 is increased and increased along the cable 66. The flexible member 34 bends in the direction of the applied tension. On the contrary, when the flexible finger 64 is bent in a convex shape when viewed from the side surface on which the cable 66 extends, the fixing point of the cable 66 provided at the second end portion 14 of the apparatus 10 and the apparatus The effective length between the fixed points of the cable 66 provided at the first end 12 of the ten is reduced, the cable 66 can be slack, and the cable 66 is straight according to the preferred embodiment of the present invention. The structure is maintained in a relaxed structure.

  Bending of the flexible member 34 and the generation of tension is further facilitated by providing a pulley system along the length of the cable 66. Specifically, the first pulley 68 and the second pulley 70 are respectively the first end 72 of the handle 16 proximate to the first end 86 of the flexible finger 64 and the flexible Located at the second end 88 of the sex finger 64. The cable 66 is wound in a loop around a first pulley 68 and a second pulley 70 proximate to the first end 74 thereof. According to a preferred embodiment, the cable 66 starts from the first end 74 of the cable 66 and extends along the flexible finger 64 and is wrapped around the second pulley 70, then Returning toward the first end 72 of the handle 16, it is wrapped around the first pulley 68. The cable 66 then extends along the device 10 and the second end 76 of the cable 66 is secured to the second end 14 of the device 10 at a location distal to the flexible member 34. ing.

  According to an alternative embodiment, the palm pulley can be a pinion that can move a longitudinal rack along the shaft by its rotational movement. By doing so, it is possible to realize a push-pull configuration capable of performing joint operation and straightening of the tip.

  By using the device 10, the flexible member 34 is simply bent to resemble the bend that the user desires to be generated at the second end 14 of the device 10. Can control the movement. In fact, the device 10 can be calibrated such that the bending of the flexible finger 64 substantially matches the bending of the flexible member 34 at the second end 14 of the device 10.

  As previously mentioned, the device is particularly adapted for delivery, manipulation and attachment of the gastric band around the patient's stomach. In consideration of this point, the gastric band 100 is inserted into the back side of the stomach and the first end and the second end are operated with the apparatus, so that the gastric band is accurately placed around the stomach. Deploy. The device is adapted for various stomachs such as those disclosed in self-pending US patent application Ser. No. 11 / 364,362 (named “Gastric Band”), which is incorporated herein by reference. It is configured to be used for a band. As will be apparent to those skilled in the art, the present invention is equally applicable to other types of implantable bands. For example, it can be used to treat stool incontinence. One such band is disclosed in US Pat. No. 6,461,292, which is incorporated herein by reference. Bands can also be used to treat urinary incontinence. One such band is disclosed in US 2003/0105385, which is hereby incorporated by reference. Bands can also be used to treat heartburn and / or gastric acid reflux. One such band is disclosed in US Pat. No. 6,470,892, which is incorporated herein by reference. Bands can also be used to treat impotence. One such band is disclosed in US Patent Application Publication No. 2003/0114729, which is incorporated herein by reference.

  While preferred embodiments have been illustrated and described, it is not intended that the invention be limited by such disclosure, but rather, all modifications and alternative constructions that fall within the concept and scope of the invention. Should be understood to include

Embodiment
(1) In a blunt dissector / gastric band attachment device that operates a joint for one hand,
A support shaft for connecting a handle provided at a first end of the device to an articulating assembly provided at a second end of the device;
Including
The handle includes an actuation mechanism coupled to the articulation assembly for actuating the articulation assembly under control;
The second end includes a proximal end and a distal end;
The distal end includes a blunt distal tip shaped and dimensioned to incise tissue without undue trauma to the tissue;
The second end also includes a suture retention notch that is shaped and dimensioned to engage and pull the gastric band,
apparatus.
(2) In the apparatus according to the embodiment (1),
The device, wherein the suture retaining notch is oriented inclined with respect to the longitudinal axis of the device.
(3) In the apparatus according to the embodiment (2),
The device, wherein the suture retaining notch is oriented at an angle of 45 ° relative to the longitudinal axis of the device.
(4) In the apparatus according to the embodiment (1),
The apparatus, wherein the articulation assembly is oriented proximally relative to the suture retaining notch.
(5) In the apparatus according to the embodiment (1),
The articulation assembly includes a flexible member comprising a first side member and a second side member.

(6) In the apparatus according to the embodiment (5),
The device, wherein the first side member and the second side member are substantially parallel and spaced apart from each other when extending along the second end of the device.
(7) In the apparatus according to the embodiment (5),
The first side member includes an inner surface with a plurality of necked down regions;
The apparatus, wherein the second side member includes an inner surface with a plurality of collar-shaped constrictions.
(8) In the apparatus according to the embodiment (5),
An apparatus, wherein a restraining band is attached around the flexible member.
(9) In the apparatus according to the embodiment (1),
The actuating mechanism includes a flexing finger;
An apparatus capable of articulating the articulating assembly by holding and moving the flexible fingers.
(10) In the device according to the embodiment (9),
The flexible finger includes a constant stress beam;
The spar has a constriction that has a tapered cross section when the flexible finger extends from the second end of the handle to the first end of the handle. The device can push and bend the flexible finger into a smooth arc.

(11) In the apparatus according to the embodiment (9),
The actuation mechanism includes a cable having a first end and a second end;
Since the first end of the cable is coupled to the flexible finger and the second end is coupled proximate to the articulation assembly, the flexible finger When the cable is bent, the cable can move and extend over the length of the increased arc to cover this length.
(12) In the device according to the embodiment (11),
A first pulley and a second pulley around which the cable is wound to amplify the displacement of the cable;
Further comprising an apparatus.

1 is a perspective view of an articulated blunt dissector / gastric band attachment device of the present invention. FIG. FIG. 3 is a detailed view of the second end of the mounting apparatus shown with reference to FIG. 1 with the restraining band removed. FIG. 2 is a detailed view of a first end of the mounting device shown with reference to FIG. 1.

Claims (10)

In one-hand articulated blunt dissector / gastric band attachment device,
A support shaft for connecting a handle provided at a first end of the device to an articulation assembly provided at a second end of the device;
Including
The handle includes an actuation mechanism coupled to the articulation assembly for actuating the articulation assembly under control;
The second end includes a proximal end and a distal end;
The distal end includes a blunt distal tip shaped and dimensioned to incise tissue without undue trauma to the tissue;
The second end also includes a suture retaining notch that is shaped and dimensioned to engage and pull the gastric band,
apparatus. The apparatus of claim 1.
The device, wherein the suture retaining notch is oriented inclined with respect to the longitudinal axis of the device. The apparatus of claim 2.
The device, wherein the suture retaining notch is oriented at an angle of 45 ° relative to the longitudinal axis of the device. The apparatus of claim 1.
The apparatus, wherein the articulation assembly is oriented proximally relative to the suture retaining notch. The apparatus of claim 1.
The articulation assembly includes a flexible member comprising a first side member and a second side member. The apparatus of claim 5.
The device, wherein the first side member and the second side member are substantially parallel and spaced apart from each other when extending along the second end of the device. The apparatus of claim 5.
The first side member includes an inner surface having a plurality of collar-shaped constricted portions,
The apparatus, wherein the second side member includes an inner surface with a plurality of collar-shaped constrictions. The apparatus of claim 5.
An apparatus, wherein a restraining band is attached around the flexible member. The apparatus of claim 1.
The actuating mechanism includes a flexible finger;
An apparatus capable of articulating the articulating assembly by holding and moving the flexible fingers. The apparatus of claim 9.
The flexible finger includes a digit with constant stress;
The spar has a constriction that has a tapered cross section when the flexible finger extends from the second end of the handle to the first end of the handle. The device can push and bend the flexible finger into a smooth arc.

Images